Quality Systems Engineer II — Lead QMS & CAPA

CryoLife, Inc.; Kennesaw, Northern (GA, KY); Hybrid; USD 95,000 - 125,000; Full time

Job summary

Artivion, Inc. in the Atlanta area is seeking a Quality Assurance professional to oversee the QMS and ensure compliance with GMP, ISO standards, and tissue banking requirements.

You will support internal and external audits, CAPA, change control, and training, driving continuous improvement with strong data reporting and risk analysis across functions. This full-time hybrid role offers collaboration with multiple product groups and a focus on quality culture in a fast-paced medical device

Qualifications

• 3+ years of experience in quality engineering or quality assurance.
• ASQ CQA/CQE/LSS and/or AATB CTBS certification preferred.
• Experience with electronic quality management systems (eQMS) and QA software tools.
• Strong analytical and problem-solving skills.

Responsibilities

• Oversee effective implementation and maintenance of the Quality Management System (QMS).
• Coordinate corrective and preventive actions (CAPA) with root cause analysis.
• Support internal and external audits and manage change control.
• Report KPIs to management and drive continuous improvement.
• Provide training and maintain the eQMS documentation.

Skills

Quality Assurance

Quality Engineering

CAPA

Auditing

Root Cause Analysis

Education

Bachelor's degree in technical/scientific field

Equivalent years’ work experience

Tools

QA Software Tools

eQMS

Job description

Artivion, Inc. in the Atlanta area is seeking a Quality Assurance professional to oversee the QMS and ensure compliance with GMP, ISO standards, and tissue banking requirements.

You will support internal and external audits, CAPA, change control, and training, driving continuous improvement with strong data reporting and risk analysis across functions. This full-time hybrid role offers collaboration with multiple product groups and a focus on quality culture in a fast-paced medical device